Efficacy and safety of ledipasvir/sofosbuvir in 5,028 Mongolian patients infected with genotype 1 hepatitis C virus: A multicenter study

被引:3
作者
Baatarkhuu, Oidov [1 ,2 ,3 ,4 ]
Lee, Jae Seung [2 ]
Amarsanaa, Jazag [4 ,5 ]
Kim, Do Young [2 ]
Ahn, Sang Hoon [2 ]
Naranzul, Nyamsuren [1 ,4 ]
Enkhtuya, Damba [4 ,5 ]
Choijamts, Nagir [4 ,5 ]
Batbayar, Purev [4 ,5 ]
Otgonbayar, Radnaa [6 ]
Saruul, Bat-Ulzii [4 ,7 ]
Gantuul, Chuluunbaatar [4 ,7 ]
Gegeebadrakh, Baljinnyam [4 ,8 ]
Tuvshinbayar, Narangerel [4 ,8 ]
Badamsuren, Dorjgotov [4 ,9 ]
Ulzmaa, Galsan [4 ,9 ]
Otgonbold, Jamiyandorj [10 ]
Han, Kwang-Hyub [2 ]
机构
[1] Mongolian Natl Univ Med Sci, Sch Med, Dept Infect Dis, Ulan Bator, Mongolia
[2] Yonsei Univ, Dept Internal Med, Coll Med, 50-1 Yonsei Ro, Seoul 03722, South Korea
[3] Mongolian Acad Med Sci, Ulan Bator, Mongolia
[4] Mongolian Assoc Study Liver Dis, Ulan Bator, Mongolia
[5] Happy Veritas Liver Diagnost Ctr, Dept Hepatol, Ulan Bator, Mongolia
[6] Mongolian Natl Univ Med Sci, Univ Gen Hosp, Dept Internal Med, Ulan Bator, Mongolia
[7] Natl Ctr Communicable Dis, Dept Hepatol, Ulan Bator, Mongolia
[8] Second State Cent Hosp, Dept Gastroenterol, Ulan Bator, Mongolia
[9] Third State Cent Hosp, Dept Gastroenterol, Ulan Bator, Mongolia
[10] Mongolian Natl Univ Med Sci, Sch Dent, Ulan Bator, Mongolia
关键词
Hepatitis C; Chronic; Ledipasvir; Sofosbuvir; Mongolia; Real-world; SOFOSBUVIR PLUS RIBAVIRIN; SIMPLE NONINVASIVE INDEX; SIGNIFICANT FIBROSIS; LEDIPASVIR; PREVALENCE; PREDICT;
D O I
10.3350/cmh.2020.0023
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background/Aims: Ledipasvir/sofosbuvir (LDV/SOF) shows high efficacy and safety in patients with genotype 1-hepatitis C virus (HCV). We aimed to investigate the efficacy and safety of LDV/SOF in real-world Mongolian patients. Methods: Between 2015 to 2019, 23 (0.5%) and 5,005 patients (99.5%) with genotype 1a and 1b HCV, respectively, were treated with a fixed-dose tablet containing 90 mg ledipasvir and 400 mg sofosbuvir for 12 weeks, and 81 patients (1.6%) with previous experience of interferon (IFN)-based treatment received additional 1,000 mg ribavirin. HCV RNA was measured at 4, 12, and 24 weeks after the first dose to determine rapid virologic response, end of treatment response (ETR), and sustained virologic response at 12 weeks after end of treatment (SVR12). Results: Most patients (n=5,008; 99.6%) achieved ETR and SVR12 without virologic relapse. Patients with genotype 1a showed low rates of ETR and SVR12 in only 16 patients (69.6%). There was no significant difference in SVR12 rate between patients regardless of IFN experience (n=81; 1.6%), cirrhosis (n=1,151; 22.9%), HCV RNA >6x10(6) IU/mL (n=866; 17.2%), or liver stiffness >9.6 kPa (n=1,721; 34.2%) (100.0%, 99.3%, 99.4%, and 99.4%, respectively). No severe adverse events (AEs) were reported, and there was no dose reduction or interruption due to AE. The most common AEs were headache (n=472; 9.4%), fatigue (n=306; 6.2%), abdominal discomfort (n=295; 5.9%), and skin rash (n=141; 2.8%). Conclusions: LDV/SOF showed high efficacy and safety for patients with genotype 1, especially 1b HCV, in Mongolia. The real-world data might be applicable to patients in other Asian-Pacific countries.
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收藏
页码:125 / 135
页数:11
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